Immunic, Inc. · NASDAQ:IMUX
Immunic — Investor Presentation (October 2026)
40 slides from Immunic's investor presentation, October 2026
Slide 1: Investor Overview
Investor Overview NASDAQ: IMUX October 2026 © Immunic, Inc. | Oct 2026 1
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements This presentation contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Slide 3: Immunic: Pivoting to a Fully Integrated Multiple Sclerosis Company
Immunic: Pivoting to a Fully Integrated Multiple Sclerosis Company Advancing a Potentially Differentiated Oral MS Therapy to Address High Unmet Needs with Near-Term Blockbuster Potential in Relapsing MS and Significant Upside Potential in Progressive MS Near-Term Value Inflection Expansion Opportuni
Slide 4: Vidofludimus Calcium Is Being Developed as a Franchise Opportunity Spanning Relapsing and Progressive MS
Vidofludimus Calcium Is Being Developed as a Franchise Opportunity Spanning Relapsing and Progressive MS PROGRAM INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 STATUS NEXT MILESTONE Vidofludimus Top-line data for both Relapsing MS Both trials fully Calcium trials expected by end ENSURE-1 enrolled (I
Slide 5: Leadership Team with Established Multiple Sclerosis Development and Commercialization Experience
Leadership Team with Established Multiple Sclerosis Development and Commercialization Experience Erik Lundgren, MBA Jason Tardio, MBA Michael A. Panzara, MD, MPH Hella Kohlhof, PhD Glenn Whaley, CPA Chief Executive Officer President & Chief Medical Officer Co-Founder & Chief Financial Officer Chief
Slide 6: Vidofludimus Calcium Has the Potential to Transform the MS Market
Vidofludimus Calcium Has the Potential to Transform the MS Market Substantial Opportunities: MS Remains a Large and Growing Market Attractive Market Dynamics § Multiple blockbuster therapies can successfully coexist, reflecting the large patient BLOCKBUSTER POTENTIAL population, heterogenous disease
Slide 7: Current DMTs Target Inflammation, None Stop/Reverse Disability Accumulation
Current DMTs Target Inflammation, None Stop/Reverse Disability Accumulation 20+ Therapies Exist for Relapsing MS, None Adequately Address the Neurodegeneration Driving Progression EDSS Disease Trajectory Over Time Bedridden / Death from MS 9–10 Wheelchair restricted 7–8 Disability Progression Indepe
Slide 8: Vidofludimus Calcium: A Unique Dual Mechanism Approach to MS
Vidofludimus Calcium: A Unique Dual Mechanism Approach to MS Potentially the Only Oral MS Drug Addressing Both PIRA and RAW Simultaneously Direct Nurr1 Activator Selective DHODH Inhibitor § Modulates gene expression directly in § Selectively targets neurons, mediating neuroprotection metabolically h
Slide 9: Key Unmet Needs Remain in Relapsing and Progressive MS
Key Unmet Needs Remain in Relapsing and Progressive MS: The Next Generation of MS Treatments Must Move Beyond Relapse Control Progression Independent Safety and Treatments for Progressive of Relapse Activity (PIRA) Tolerability Multiple Sclerosis § PIRA continues to occur even in patients § Many app
Slide 10: Addressing Near-Term Unmet Needs in Relapsing Multiple Sclerosis
Addressing Near-Term Unmet Needs in Relapsing Multiple Sclerosis
Slide 11: Vidofludimus Calcium in Relapsing MS: Even with 20+ Approved DMTs, Significant Unmet Needs Exist
Vidofludimus Calcium in Relapsing MS: Even with 20+ Approved DMTs, Significant Unmet Needs Exist Relapsing MS ~400K Diagnosed Patients in the U.S.1,2 Vidofludimus calcium is a key late-stage asset with NDA submission targeted in mid-2027, and expected › High unmet needs remain despite numerous appro
Slide 12: EMPhASIS: Strong Efficacy, Durable Long-Term Benefit, and Favorable Safety in RRMS
EMPhASIS: Strong Efficacy, Durable Long-Term Benefit, and Favorable Safety and Tolerability in Relapsing-Remitting MS Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial (NCT03846219) 268 patients in 36 centers across four European countries Screening Main Treatment Peri
Slide 13: Robust Reduction in MRI Lesion Activity Over 24 Weeks
Robust Reduction in MRI Lesion Activity Over 24 Weeks Primary and Key Secondary Endpoints Both Highly Statistically Significant, Pooled Cohorts 1&2 Reduction in CUA Lesions up to Week 24 Reduction in Gd+ Lesions up to Week 24 0 0 0 7 0 5 0 -13% -10 -10 6 -20 4 -20 5 -30 -30 4 -40 3 -40 -50 -50 3 -60
Slide 14: Encouraging Trend on Risk of Relapse, Despite Study Size and Duration
Encouraging Trend on Risk of Relapse, Despite Study Size and Duration Relative risk of relapse reduced by 42% Proportion of patients with relapse HR: HR: 0.58, 0.58 p=0.19 (HR: 0.58, p=0.19) in 30 mg group vs. placebo to Week 24 23% Apparent onset of effect within 6-8 weeks, increasing over time 14%
Slide 15: Favorable Safety and Tolerability Profile with Similar Incidence to Placebo
Favorable Safety and Tolerability Profile with Similar Incidence to Placebo Vidofludimus Vidofludimus Safety and Tolerability Endpoints Placebo Calcium 30 mg Calcium 45 mg Key Safety Observations: Any treatment-emergent adverse event 44% 45% 41% § No signal for liver injury Treatment-emergent advers
Slide 16: Open-Label Extension Phase: High Retention Rate with 92.3% of Patients CDW-Free at 144 Weeks
Open-Label Extension Phase: High Retention Rate with 92.3% of Patients CDW- Free at 144 Weeks 100.0% 98.0% 97.2% 100% 94.6% 93.3% 93.3% 92.3% 90% › At week 144, 92.3% of patients % Patients Free of 12wCDW Events 80% remained free of 12-week CDW, with 70% 92.7% free of 24-week CDW 60% 50% › Low disco
Slide 17: ENSURE Phase 3: Two Fully Enrolled Pivotal Trials
ENSURE Phase 3: Two Fully Enrolled Pivotal Trials Designed to Confirm Immunomodulatory Effects Specifically Through Relapse Reduction Randomized, Double-Blind, Placebo-Controlled Trials (NCT05134441 & NCT05201638) Screening OLE (optional) Main Treatment Period (Blinded) § More than 100 sites in 15 c
Slide 18: Recruited Patients in ENSURE Similar to Population Recruited into EMPhASIS
Recruited Patients in ENSURE Similar to Population Recruited into EMPhASIS Total of 2,221 Enrolled Patients, Nearly 50% Received Prior MS Treatment ENSURE Baseline Patient Characteristics1 EMPhASIS Baseline Patient Characteristics ENSURE-1 (N=1,121) ENSURE-2 (N=1,100) EMPhASIS (N=249)2 Mean age (SD)
Slide 19: Primary and Secondary Endpoints Selected to Ensure Robust Assessment of Outcomes
Primary and Secondary Endpoints Selected to Ensure Robust Assessment of Clinical and Imaging Outcomes Meaningful to People with MS ENSURE-1 Pooled ENSURE Trials ENSURE-2 “ I hope to see different kinds of MS drugs: ones that stop Primary Primary Time to First Relapse (TTFR) Net Clinical Benefit Time
Slide 20: Vidofludimus Calcium in Relapsing MS: Targeted NDA Submission Driven by Near-Term Pivotal Readouts
Vidofludimus Calcium in Relapsing MS: Targeted NDA Submission Driven by Near-Term Pivotal Readouts › Fully enrolled Phase 3 ENSURE-1 and Robust Phase 2 EMPhASIS Results on Inflammatory Endpoints ENSURE-2 trials with top-line data expected by year-end 2026 › NDA submission in the U.S. targeted for Ph
Slide 21: Potential to Change Treatment Paradigm in Progressive Multiple Sclerosis
Potential to Change Treatment Paradigm in Progressive Multiple Sclerosis
Slide 22: Progressive MS: Potential to Change Treatment Paradigm
Progressive MS: Potential to Change Treatment Paradigm Limited Treatment Options Available to Date With Many Patients Continuing to Worsen Despite Treatment Progressive MS § New treatments should tackle the processes responsible for the continuous accumulation of disability in ~150K Diagnosed Patien
Slide 23: CALLIPER: Phase 2 Clinical Trial in Progressive MS
CALLIPER: Phase 2 Clinical Trial in Progressive MS Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (NCT05054140) 467 Adult Patients Randomized, >340 Patients Continuing in OLE* Inclusion Criteria Screening OLE Main Treatment Period (Blinded) Period (optional) › Patients aged 18 to 65
Slide 24: Exploratory MRI Outcomes Revealed Consistent, Directionally Favorable Signals
Exploratory MRI Outcomes Revealed Consistent, Directionally Favorable Signals Even Though the Primary PBVC Endpoint Was Not Met Annualized PBVC rate up to 120 weeks: 4.7%; 95% CI, -0.285 to 0.379; p=0.78 Nominal regional atrophy differences favored vidofludimus calcium although not significant: 15.7
Slide 25: Consistent Effects on Disability Worsening and Improvement, Even in Non-Active Patients
Vidofludimus Calcium Showed Consistent Effects on Disability Worsening and Improvement, Even in Non-Active Patients 24wCDW 24wCDI Favors IMU-838 Favors Placebo Favors Placebo Favors IMU-838 Consistent numerical reductions in 24-week CDW, together with an approx. 2-fold increase in 24-week CDI versus
Slide 26: Consistent Effects on Disability Worsening and Improvement, Even in Non-Active Patients
Vidofludimus Calcium Showed Consistent Effects on Disability Worsening and Improvement, Even in Non-Active Patients 24wCDW 24wCDI Favors IMU-838 Favors Placebo Favors Placebo Favors IMU-838 Consistent numerical reductions in 24-week CDW, together with an approx. 2-fold increase in 24-week CDI versus
Slide 27: Favorable Safety and Tolerability Profile at 45 mg with No Signal for Liver Injury
Favorable Safety and Tolerability Profile at 45 mg with No Signal for Liver Injury Five Most Common TEAE Events N of patients / n of events 45 mg Vidofludimus Calcium n=235 Placebo n=232 Total Urinary tract infection 39 / 57 36 / 49 75 / 106 Headache 10 / 16 16 / 42 26 / 58 Back pain 9 / 11 17 / 24
Slide 28: Vidofludimus Calcium in Progressive MS: Treatment Paradigm Changing Potential
Vidofludimus Calcium in Progressive MS: Treatment Paradigm Changing Potential Strong Imaging and Exploratory Disability Phase 2 Efficacy Signals* › Initiation of a Phase 3 clinical trial in Favorable and Consistent Safety Profile at 45 mg Dose progressive MS expected later this year Positive Phase 2
Slide 29: Commercial Opportunity
Commercial Opportunity
Slide 30: The U.S. Relapsing MS Market is Large, Continues to Grow, and Oral DMTs Remain a Sizable Class
The U.S. Relapsing MS Market is Large, Continues to Grow, and Oral DMTs Remain a Sizable Class ~7% CAGR Total U.S. Relapsing MS Patient Share by Class2 ~$25B 51% anti-CD20 ~$17B 28% Orals 2025 13% Platform injectables 8% Other high-efficacy mAbs 2026 2032 Sales numbers in G7 countries (U.S., UK, Can
Slide 31: Not a Winner Take All Market: ~90K U.S. Patients Making a Treatment Decision Each Year
Not a Winner Take All Market: Dynamic with ~90K U.S. Patients Making a Treatment Decision Each Year, with Another ~125K Currently Untreated THE RELAPSING MS PATIENT JOURNEY CREATES MULTIPLE TREATMENT DECISION POINTS relapsing MS patients initiate ~45K therapy each year1 01 02 03 04 INITIATE SWITCH S
Slide 32: MS Treatment Is Highly Personalized for Each Patient and Influenced by Patient Preference and HCPs
MS Treatment Is Highly Personalized for Each Patient and Influenced by Both Patient Preference and MS Treatment Philosophies by HCPs MS Treaters Are Highly Heterogeneous with Diverse Personalized by Patient Characteristics1,2 Treatment Philosophies and Prescribing Behaviors1,2 Disease Severity Age /
Slide 33: Vidofludimus Calcium Is Targeted to Deliver the Optimal Balance of Treatment Attributes
Vidofludimus Calcium Is Targeted to Deliver the Optimal Balance of the Treatment Attributes That Matter Most to Patients and HCPs Safety Neuroprotection/Anti-inflammation Potentially reduces key safety concerns Combines neuroprotective effects through associated with currently marketed DMTs, Nurr1 a
Slide 34: Vidofludimus Calcium Could Address Several Large, Underserved Relapsing MS Patient Segments
Vidofludimus Calcium Could Address Several Large, Underserved Relapsing MS Patient Segments Treated Relapsing Addressable Patient Segments for Size of Opportunity MS Patients Vidofludimus Calcium Relapsing MS Patients seeking Patients § A favorable who risk-benefit Patients who ~100K relapsing MS co
Slide 35: Vidofludimus Calcium Has the Potential to Address Significant Opportunities in Relapsing MS
Vidofludimus Calcium Has the Potential to Address Significant Opportunities in Relapsing MS LARGE AND GROWING MARKET NOT A WINNER-TAKE-ALL MARKET 1 The U.S. relapsing MS market is ~$17B today and projected to reach ~$25B by 2032, with oral DMTs remaining a significant treatment class 2 Patients init
Slide 36: Summary and Outlook
Summary and Outlook
Slide 37: Building a Leading MS Company: A Phased Commercial Strategy
Building a Leading MS Company: A Phased Commercial Strategy Relapsing MS Establishes Commercial Foundation; Progressive MS Drives Long-Term Value Creation BECOME A GLOBAL MS LEADER (2032+) SCALE & GENERATE CASH FLOW Capture a substantially larger market (2028-2032) opportunity through expansion into
Slide 38: Value Creation Roadmap
Value Creation Roadmap Multiple Catalysts Through 2030 2H 2026 2027 2028 Relapsing MS ENSURE-1 and ENSURE-2 Top-line data expected Targeted relapsing MS NDA Potential relapsing MS U.S. by end of 2026 submission in mid-2027 regulatory approval in 2028 Progressive MS Progressive MS Phase 3 CALLIPER an
Slide 39: Immunic: Pivoting to a Fully Integrated Multiple Sclerosis Company
Immunic: Pivoting to a Fully Integrated Multiple Sclerosis Company Advancing a Potentially Differentiated Oral MS Therapy to Address High Unmet Needs with Near-Term Blockbuster Potential in Relapsing MS and Significant Upside Potential in Progressive MS Near-Term Value Inflection Expansion Opportuni
Slide 40: Thank you!
Thank you! Jessica Breu Vice President Investor Relations & Communications Phone: +1-332-255-9819 Immunic, Inc. Immunic AG Immunic Australia Pty. Ltd. 1200 Avenue of the Americas Lochhamer Schlag 21 Melbourne Email: ir@imux.com New York, NY 10036 82166 Gräfelfing (Munich) Australia Web: www.imux.com